TEST:

Droplex EGFR Mutation Test v2

"Our research abstracts proving the clinical utility of our Dropplex lung cancer panel test have been accepted by ASCO Breakthrough and the World Congress of Lung Cancer in 2024. At ASCO Breakthrough, we presented the results proving that our Dropplex lung cancer panel test can detect 180 mutations in 11 genes related to lung cancer through liquid biopsies such as cancer tissue and blood. At the World Congress of Lung Cancer to be held on September 8, we plan to present that our Dropplex lung cancer panel test showed consistency in the diagnostic results of the NGS diagnostic method in a clinical study conducted on 35 patients with non-small cell lung cancer (NSCLC)."

"Gencurix...announced...that its abstract of a performance study on a companion diagnostic test for lung cancer was accepted at the 2024 ASCO Breakthrough (American Society of Clinical Oncology)...Gencurix's 'Droplex NSCLC Panel Test' is a digital PCR-based lung cancer companion diagnostic test that can detect multiple genetic mutations simultaneously. In this research abstract, an innovative technology was announced that can detect 180 mutations in 11 lung cancer-related genes through liquid biopsies such as blood as well as cancer tissue."

A total of 1,418 EGFR E20ins mutations were collected from six studies (FoundationInsights, Geneseeq Technology Inc, mobocertinib phase I/II trial, poziotinib phase II trial, sunvozertinib phase I trial, and Samsung Medical Center) and reorganised according to Human Genome Variation Society (HGVS) nomenclature. To ensure comprehensive coverage in real-world settings, it is essential to standardise the annotations for each variant, for example using the HGVS nomenclature. The accurate classification and analysis of drug responsiveness in EGFR E20ins necessitate consideration of the nomenclature, particularly with respect to the locations where the actual mutations occur.

"Gencurix's lung cancer companion diagnostic test (product name: Droplex EGFR Mutation Test v2) has been approved for sale in Australia...This is the second approval in Australia after endometrial cancer (POLE), and both products are the first digital PCR-based diagnostic products to be approved in Australia."

"Six types of Gencurix' companion diagnostic tests (Droplex) have been approved for sale in Turkiye, covering most of the Droplex test portfolio in Romania, Colombia, and Germany."

"Gencurix...announced on the 29th that its companion diagnostic test had received approval from the Ministry of Food and Drug Safety in Thailand. The product approved this time is 'Droplex EGFR Mutation Test v2', a liquid biopsy companion diagnostic test for lung cancer from Gencurix."

"Molecular diagnosis company Gencurix's companion diagnostic platform 'Droplex' received sales permission from the UAE Ministry of Health and Welfare on the 9th...The product approved this time is 'Droplex EGFR Mutation Test v2', a liquid biopsy companion diagnostic test for lung cancer. It can detect a total of 107 gene mutations and is characterized by improved accuracy by using highly sensitive digital gene amplification (PCR) technology."

This study investigated the distribution of EGFR E20ins in the Asian population, with p.A767_V769dup and p.S768_D770dup being the most frequently observed mutations. Since some studies have reported single EGFR E20ins sequences using different names, it is important to be cautious when describing EGFR E20ins. To ensure comprehensive coverage in real-world settings, each method used for the detection of EGFR E20ins must be annotated according to the HGVS nomenclature.

"Gencurix...has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2. This product is a companion diagnostic test designed to detect EGFR mutations commonly found in NSCLC patients and guide the selection of appropriate targeted anticancer therapies based on the test results....Compared to existing EGFR mutation tests using RT-PCR, this product demonstrates significantly higher sensitivity. This makes it capable of accurately detecting mutations even when plasma samples are used as the specimen....Notably, this product has an additional strength in its ability to detect Exon 20 Insertion..."

"Gencurix announced...that it had signed a local agency supply contract with German Biotype...Gencurix plans to supply the Dropplex diagnostic kit, a digital PCR-based cancer companion diagnostic product, to Germany and other European countries through Biotype. Gencurix received European in vitro diagnostic medical device certification (CE-IVD) for six Dropplex products."

"Gencurix...announced on the 7th that 'Dropplex EGFR Mutation Test V2' has obtained manufacturing permission from the Ministry of Food and Drug Safety...Gencurix's Dropplex EGFR Mutation Test V2 is a diagnostic kit product that enables patients to select the most suitable targeted therapy by detecting mutations in the EGFR test, which is the most basic and important test in the field of cancer companion diagnosis."

"Gencurix...announced on the 21st that it has obtained European certification (CE) for 6 types of 'Dropplex', a molecular diagnostic (PCR)-based cancer companion diagnostic product...Dropplex consists of products that target a total of six biomarkers (biomarkers) including lung cancer (EGFR v2, c-MET), colorectal cancer (KRAS), endometrial cancer (POLE), breast cancer (PIK3CA) and thyroid cancer (BRAF)."

"Gencurix...announced on the 25th that 'Composition for detecting epithelial cell growth factor receptor gene mutation and kit containing same' in the United States The patent has finally been obtained...The patent is about a method and kit composition for detecting EGFR mutations, which are mainly found in lung cancer patients. This was applied to 'Droplex EGFR Mutation Test (hereafter Dropplex EGFR), the world's first digital PCR-based IVD (medical device certification) product developed by Gencurix."